US Pharm. 2014;39(10):7.
Silver Spring, MD—Similar to the Orange Book for generic drugs, the FDA has published the first Purple Book for biologics and biosimilars. The Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations catalogs all biological products licensed by the FDA, as well as any biosimilar and interchangeable products that may be approved in the future. It will serve as the biopharmaceutical equivalent and function in the same way as the Orange Book, but not as extensive at this initial stage. Although no biosimilar or interchangeable products have received FDA approval to date, this is expected to be a growing U.S. market, as the first two applications for biosimilars were recently submitted to the FDA for review.
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